# INTerpath-001 (V940-001)

Source: https://onco.cc/trials/interpath-001/  
OnCo record `interpath-001` (Trial). Data CC BY-NC 4.0, attribute "Data from OnCo (onco.cc)"; commercial use needs a licence.

## TL;DR

INTerpath-001 was the first positive phase 3 trial of a personalised cancer vaccine, announced 19 August 2026.

## Summary

INTerpath-001, also V940-001, trial NCT05933577 sponsored by Moderna and Merck and announced on 19 August 2026, was the first positive phase 3 trial of a personalised cancer vaccine, testing intismeran autogene plus pembrolizumab against pembrolizumab alone after resection of stage IIB to IV melanoma. It randomised 1,137 patients, met its primary recurrence-free survival endpoint and its key secondary distant metastasis-free survival endpoint with no new safety signals, and full data are expected at a late-2026 congress with filings to follow; sister trials run in lung, kidney, bladder and skin squamous cancers. It confirms the phase 2b KEYNOTE-942 signal, and whether the effect size justifies bespoke manufacturing for every patient is the open question.

## Fields

- Kind: Trial
- Status: positive
- Last checked: 2026-09-04
- Registry id: NCT05933577
- Phase: 3
- Setting: Adjuvant resected stage IIB-IV melanoma: intismeran autogene + pembrolizumab vs pembrolizumab
- Sponsor: Moderna / Merck
- Enrolled: 1137
- Result: RFS and DMFS significantly improved (HRs pending presentation).
- Outcomes: Recurrence-free survival: Intismeran autogene + pembrolizumab vs Placebo + pembrolizumab; Distant metastasis-free survival: Intismeran autogene + pembrolizumab vs Placebo + pembrolizumab
- Replication: Confirms the phase 2b KEYNOTE-942 signal (RFS HR 0.51 at 3 years) in a randomised phase 3; full data pending.

## Sources

- ClinicalTrials.gov NCT05933577: https://clinicaltrials.gov/study/NCT05933577
- Merck press release: https://www.merck.com/news/merck-and-moderna-announce-phase-3-interpath-001-trial-of-intismeran-autogene-plus-keytruda-met-endpoints-of-recurrence-free-survival-rfs-and-distant-metastasis-free-survival-dmfs-in-patient/

## Connected records

- cancers: [Melanoma](https://onco.cc/cancers/melanoma/), [Stage IIB and IIC melanoma](https://onco.cc/cancers/stage-ii-melanoma/), [Stage III melanoma (after surgery)](https://onco.cc/cancers/stage-iii-melanoma/)
- technologies: [Personalised neoantigen (mRNA) vaccines](https://onco.cc/technologies/neoantigen-mrna-vaccine/)
- drugs: [Intismeran autogene](https://onco.cc/drugs/intismeran-autogene/), [Pembrolizumab](https://onco.cc/drugs/pembrolizumab/)
- companies: [Moderna](https://onco.cc/companies/moderna/)
- people: [Jeffrey S. Weber](https://onco.cc/people/jeffrey-weber/)
- terms: [Event-free / disease-free survival (EFS, DFS, iDFS, RFS)](https://onco.cc/terms/efs/)
- pairings: [Personalised neoantigen vaccine + PD-1 blockade](https://onco.cc/pairings/vaccine-plus-pd1/)
- roadmaps: [Immunotherapy roadmap: Coley's toxins → checkpoint inhibitors → engineered immunity](https://onco.cc/roadmaps/immunotherapy-roadmap/)
- bottlenecks: [Cold tumours and the immunosuppressive microenvironment](https://onco.cc/bottlenecks/b-tme-immunosuppression/)
- ideas: [Vaccines aimed only at mutations shared by every tumour cell](https://onco.cc/ideas/idea-bio1-clonal-neoantigen-vaccines/)
- key papers: [KEYNOTE-942: a personalised mRNA cancer vaccine plus pembrolizumab after melanoma surgery](https://onco.cc/key-papers/paper-keynote-942-lancet-2024/), [Rojas 2023: a personalised mRNA vaccine trained T cells against each patient's pancreatic cancer, and those who responded stayed cancer-free longer](https://onco.cc/key-papers/paper-rojas-mrna-neoantigen-vaccine-pancreatic-nature-2023/)

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